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临床试验/NCT01876732
NCT01876732已完成不适用

Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients

Northwell Health1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
132
试验地点
1
主要终点
Change in Amount of Epogen Required

研究概览

简要总结

Vitamin B12 has several important functions in the body, two of which are production of red blood cells and the maintenance of a healthy nervous system. When vitamin B12 is deficient, abnormal red blood cells form. These cells are called megaloblasts. The end result is a decreased number of red blood cells; a condition called anemia. Some symptoms of anemia include fatigue, weakness, shortness of breath, and pallor. Vitamin B12 is also important in maintaining a healthy nervous system. Nerves are surrounded by an insulating material that helps them conduct impulses. Patients with low B12 levels who receive this vitamin in injection form, state that there quality of life is better. Anemia in Hemodialysis patients is treated with Epogen, a synthetic material which helps your body make blood cells. The investigators believe that if you have a low vitamin B12 level in your blood and the investigators give you the vitamin during dialysis your requirement for epogen will be lower and you will be able to produce blood cells better. When evaluating for Vitamin B12 deficiency a special test is needed called methylmalonic acid level (MMA). This is a blood test that will be performed and when this level is high and your vitamin B12 level is in the low normal range the investigators can make a diagnosis of vitamin B12 deficiency.

详细描述

BACKGROUND: Vitamin B12 deficiency may have deleterious effects on end stage renal disease (ESRD) patients on maintenance hemodialysis, and may increase erythropoietin stimulating agent (ESA) resistance, yet little is known about its prevalence in this population.

METHODS: Serum vitamin B12 and methylmalonic acid (MMA) levels were drawn from ESRD patients prior to hemodialysis. All patients with MMA levels greater than 800 nmol/L had peripheral smears evaluated for B12 deficiency. Those with confirmatory smears were considered to be deficient and received intramuscular vitamin B12 injections for 4 months. Post-treatment MMA levels and smears were obtained. Erythropoietin dosages were monitored throughout the treatment period.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • · Patients on Hemodialysis for at least 6 months
  • Patients on stable dose of epogen and iron supplementation for at least 1 month prior to B12 and MMA assay.

排除标准

  • · On B12 treatment
  • Hematological Cancer
  • Methotrexate use
  • Alcohol use greater then 2 drinks per day
  • Vegetarian Diet
  • Gastric Surgery
  • Inflammatory Bowel Disease
  • Pernicious Anemia
  • Recent transfusion

研究组 & 干预措施

Vitamin B12

Experimental

Those with an MMA over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.

干预措施: Vitamin B12 (Drug)

结局指标

主要结局

Change in Amount of Epogen Required

时间窗: Baseline and 4 months

The effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients

次要结局

  • Change in Quality of Life(3 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suzanne El-Sayegh

Nephrology Attending, Assoc. Chair of Medicine

Northwell Health

研究点 (1)

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